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| Name | Class |
|---|---|
| Mount Sinai Hospital, Canada | OTHER |
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The study aims to investigate the olfactory TDI score (Threshold, Discrimination, Identification) using the Sniffin' sticks test for patients with chronic rhinosinusitis with nasal polyps (CRSwNP) on dupilumab. Twenty-seven adult patients will be followed up during the treatment with dupilumab on three visits to the Otolaryngology Clinic (Baseline, 3 months and 6 months).
The primary endpoint will be the TDI score. Nasal polyp score, Quality of Olfactory Disorders - negative symptoms (QOD-NS symptom scores), SNOT-22 will be secondary endpoints.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dupilumab group | Experimental | Patients with CRSwNP will have an initial dose of 600 mg of dupilumab, and 5 additional doses of 300mg every 4 weeks for 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT] | Drug | Dupilumab will be administered subcutaneously for 6 months (1 initial 600mg dose + 5 300mg doses every 4 weeks) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in the Smell Threshold, Identification and Discrimination (TDI score) at week 12 and week 24. | The Sniffin' Sticks test involves testing odor for threshold and discrimination whilst blind folded and secondly odor identification. The sum of four odors responses ranges from 0-16. The sum of total score from odor Threshold, Discrimination and Identification (TDI) is a maximum of 48 points. The total score is graded as; normosmia equals or over 30.5 points, hyposmia 16.5-30 points and anosmia less than 16.5 points. | Baseline, 12 weeks and 24 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in the Nasal Polyps score at weeks 12 and 24. | Nasal Polyps score is the sum of the right and left nostril scores (endoscopic assessment). Total score ranges from 0 (no polyps) to 8 (large polyps on for each nostril [4+4] ). | Baseline, 12 weeks and 24 weeks. |
| Change from Baseline in the Sino-nasal outcome test- 22 (SNOT-22) at weeks 12 and 24. |
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Inclusion Criteria:
Exclusion Criteria:
Patients with olfactory loss from other causes such as:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cristian Dihel, MD | Contact | +15196466100 | 61125 | cristian.dihel@sjhc.london.on.ca |
| Name | Affiliation | Role |
|---|---|---|
| Leigh J Sowerby, MD, FRCS | St. Joseph's Hospital London, ON, Canada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Joseph's Health Care | Recruiting | London | Ontario | N5A 4V2 | Canada |
No plan to make IPD available.
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| ID | Term |
|---|---|
| C582203 | dupilumab |
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Single group 6 months treatment with Dupilumab.
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SNOT-22 is a validated questionnaire to assess the impact of chronic rhinosinusitis on patients' quality of life. Patient grades the impact of 22 potential symptoms in their life, by choosing from 0 [no problem] to 5 [problem as bad as it can be]. Highest possible score is 10 (worst quality of life); minimal clinically important change ≥ 8.90 |
| Baseline, 12 weeks and 24 weeks. |
| Change from Baseline in the QOD-NS at weeks 12 and 24. | Quality of Olfactory Disorders - negative symptoms (questionnaire) | Baseline, 12 weeks and 24 weeks. |